FDA UDI
In Commercial Distribution
🇺🇸 United States
Senza
DI: 00813426021227
·
Model: NIPG3000U
·
NEVRO CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Senza
- Primary DI
- 00813426021227
- Version / Model
- NIPG3000U
- Catalog Number
- NIPG3000U
- Company Name
- NEVRO CORP.
- Labeler DUNS
- 926599155
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-07
- Public Version
- 1
- Public Version Date
- 2025-11-17
- Public Version Status
- New
- Public Device Record Key
- bd16e952-4f27-4167-b2a3-58e0ffb50e87
Device Description
IPG Model IPG3000 Kit, NIPG3000U
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64970 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable | An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813426021227 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130022 | 000 |